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Intertransverse Process Block Versus M-TAPA Block After Laparoscopic Hysterectomy

15. května 2026 aktualizováno: Beste Mutlu Dağlıoğlu, Antalya City Hospital

Intertransverse Process Block Versus M-TAPA Block After Laparoscopic Hysterectomy: A Prospective Randomized Controlled Trial

This randomized clinical trial aims to evaluate and compare the analgesicefficacy of the Intertransverse Process Block (ITPB) and the Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) in patients undergoing laparoscopic hysterectomy. The primary outcome is the Visual Analog Scale (VAS) score within the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block- related complications and adverse effects (hematoma, pneumothorax, local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.

Přehled studie

Detailní popis

Study Objective: This research aims to obtain objective data to demonstrate the effectiveness of two regional block techniques in acute pain management. The primary objective is to compare the effects of Intertransverse Process Block (ITPB) and M-TAPA Block on Visual Analog Scale (VAS) scores in patients undergoing laparoscopic hysterectomy. Secondary outcomes include evaluating the impact of these blocks on total opioid consumption within the first 24 hours, requirement for rescue analgesia, block-related and systemic complications (hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.Materials and Methods: This prospective, randomized clinical study will include voluntary patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) 18-35 kg/m². All participants will be informed about the study protocol in detail, and written informed consent will be obtained prior to inclusion. Patients will receive instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10 denotes the worst imaginable pain. Patients who meet the exclusion criteria will be withdrawn from the study. Participants will be randomly assigned to one of two groups using a computer-generated simple randomization method (https://www.randomizer.org). Randomization will be performed by a team member uninvolved in patient care, who will also prepare sealed opaque envelopes to conceal group allocation until shortly before block administration.Study Groups and Block Procedures: Group ITP will receive a bilateral ITP block, and Group M-TAPA will receive a bilateral M-TAPA block. All patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO2), and non-invasive blood pressure prior to the block. Premedication with intravenous midazolam (0.02 mg/kg) will be administered.ITP Block :Intertransverse Process Block (ITP) will be performed 30 minutes prior to surgery with the patient in a sitting position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned along the medial border of spinous processes level of the T10 thoracic vertebrae.Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T10 level, will be identified. Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline demonstrating separation within the intertransverse plane. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on each side under ultrasound guidance.M-TAPA Block:The Block will be performed 30 minutes prior to surgery with the patient in a supine position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned obliquely along the costal margin at the level of the 10th costal cartilage.Anatomical landmarks, including the costal cartilage, rectus abdominis muscle, transversus abdominis muscle, and internal oblique muscle will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted toward the perichondrial plane beneath the 10th costal cartilage under ultrasound guidance. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on each side under ultrasound guidance.General Anesthesia Upon entry into the operating room, patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive blood pressure. Anesthesia will be induced with intravenous propofol (2 mg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), fentanyl citrate (1.5 mcg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), and rocuronium bromide (0.6 mg/kg, Muscuron®, Koçak Farma Pharmaceutical and Chemical Industry Co., Turkey). Anesthesia maintenance will be provided using 6% desflurane in a 40%oxygen-air mixture and a continuous remifentanil infusion at 0.05 mcg/kg/min. Mechanical ventilation settings will be adjusted to deliver a tidal volume of 6-8 mL/kg with end-tidal CO# maintained at 30-35 mmHg. Anesthetic depth will be monitored continuously using a Bispectral Index (BIS™) monitor (Medtronic plc, Dublin, Ireland), targeting a BIS value of 40-60. If heart rate or mean arterial pressure increases >20% from baseline, the remifentanil dose will be titrated accordingly.Thirty minutes before the end of surgery, all patients will receive 15 mg/kg of intravenous paracetamol (e.g., Paracerol®, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey) and 1 mg/kg of intravenous tramadol. To prevent nausea and vomiting, 4 mg intravenous ondansetron will be administered. Patients with adequate spontaneous ventilation will be extubated and transferred to the post-anesthesia care unit (PACU). Hemodynamic Monitoring Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and oxygen saturation will be recorded at the following time points: pre-induction (baseline), 5 minutes after induction, 5 minutes after surgical incision, 15 minutes after incision, and at the end of surgery.Postoperative Pain and Analgesic Use: Pain will be assessed using the VAS at rest (static) and during movement (dynamic) at 0, 1, 4, 8, 12, and 24 hours postoperatively.All patients will use patient-controlled analgesia (PCA) without a basal infusion. The PCA device will be set to deliver 1 mg of morphine (0.2 mg/mL concentration) with a 10-minute lockout interval. Patients will be instructed to press the PCA button when VAS ≥4. Intravenous paracetamol will be administered every 8 hours. Rescue analgesia with intravenous tramadol (1 mg/kg) will be provided if VAS scores remain ≥4. The total amounts of opioids, NSAIDs, and other analgesics will be recorded.Postoperative Recovery Quality Postoperative recovery will be assessed using the 15-item Quality of Recovery-15 (QoR-15) questionnaire, which evaluates five domains: pain, physical comfort, physical independence, psychological support, and emotional state.Patient Satisfaction Satisfaction will be evaluated using a 5-pointLikert scale, where 1 = not satisfied and 5 = very satisfied, based on verbalfeedback from both the patient and the surgeon.Nausea and Vomiting: Nausea and vomiting will be scored using a 4-point scale:0 = none1. = mild2. = moderate3. = severe Potential Complications Any complications associated withthe block or the surgical procedure (e.g., hematoma, pneumothorax,local anesthetic systemic toxicity, vascular puncture, or infection) will berecorded.

Typ studie

Intervenční

Zápis (Odhadovaný)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Patients aged 18-65 years
  • ASA physical status I-III
  • Scheduled for elective laparoscopic hysterectomy
  • Body mass index (BMI) 18-35 kg/m²
  • Ability to understand and use the patient-controlled analgesia (PCA) device
  • Ability to provide written informed consent

Exclusion Criteria:

  • Refusal to participate
  • Allergy to local anesthetics
  • Infection at the injection site
  • Coagulopathy or ongoing anticoagulant therapy
  • Chronic opioid use or opioid dependence
  • Severe hepatic or renal insufficiency
  • Pregnancy or breastfeeding
  • Cognitive impairment or inability to communicate pain scores
  • Body mass index (BMI) >35 kg/m²

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Blokáda intertransverzálních výběžků
A linear ultrasound probe will be positioned along the medial border of spinous processes level of the T10 thoracic vertebrae.Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T10 level, will be identified. Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes. Proper needle placement will be confirmed with the injection of 1-2 mmL isotonic saline demonstrating separation within the intertransverse plane. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.
Aktivní komparátor: M-TAPA Block
A linear ultrasound probe will be positioned obliquely along the costal margin at the level of the 10th costal cartilage. Anatomical landmarks, including the costal cartilage, rectus abdominis muscle, transversus abdominis muscle, and internal oblique muscle will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle will be inserted toward the perichondrial plane beneath the 10th costal cartilage under ultrasound guidance. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Postoperative pain intensity (VAS score)
Časové okno: 0, 1, 4, 8, 12, and 24 hours after surgery
Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.
0, 1, 4, 8, 12, and 24 hours after surgery

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Požadavek na záchrannou analgezii
Časové okno: V prvních 24 hodinách po operaci
V prvních 24 hodinách po operaci
Předcházení pooperační nevolnosti a zvracení
Časové okno: V prvních 24 hodinách po operaci
V prvních 24 hodinách po operaci
Celková spotřeba opioidů prostřednictvím analgezie řízené pacientem (PCA)
Časové okno: Během prvních 24 hodin po operaci
Během prvních 24 hodin po operaci
Quality of recovery assessed using the QoR-15 questionnaire
Časové okno: At 24 hours postoperatively
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, which ranges from 0 to 150, with higher scores indicating better recovery.
At 24 hours postoperatively
Potential Complications
Časové okno: Within the first 24 hours postoperatively
Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, or infection) will be recorded.
Within the first 24 hours postoperatively
Patient satisfaction
Časové okno: At 24 hours postoperatively
Patient satisfaction will be assessed using Likert scala (1 =very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.
At 24 hours postoperatively

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

18. listopadu 2026

Primární dokončení (Odhadovaný)

30. září 2027

Dokončení studie (Odhadovaný)

30. listopadu 2027

Termíny zápisu do studia

První předloženo

15. května 2026

První předloženo, které splnilo kritéria kontroly kvality

15. května 2026

První zveřejněno (Aktuální)

20. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • ITPvsMTAPA-LH

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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